Protocol of the CONSORT and SPIRIT Extension for multicenter clinical trials.

ABSTRACT:

Background

Multicenter clinical trials play an indispensable role for assessing the efficacy of a new intervention or treatment, particularly in Phase II or III studies. Previous studies have shown that these studies often suffer from inadequate reporting of key details related to their design, implementation, and analysis, both in the protocol and final reports. This limitation reduces the practical and scientific value of the findings. Furthermore, the lack of guidance on how to report multicenter features can contribute to poor reporting. Therefore, this study aims to develop guidelines to improve the reporting of multicenter trials, including two Extensions of the CONSORT 2010 and the SPIRIT 2013.

Methods/design

The standard methodology for developing health research rep

SUBMITTER: Zhang X 

PROVIDER: S-EPMC10540686 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature